Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

Tokyo Medical University

Status: Enrolling

Conditions: Fractures, Bone; Fracture Malunion, Bone

Treatments: Device: Image fusion system

Study type: Interventional

Funder types: Other

Identifiers

NCT03764501

18-19

Details and patient eligibility

About

Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

Full description

The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fracture paitents need osteosynthesis

Exclusion criteria

• Fracture patients under 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Image fusion group (Image fusion)

Active Comparator group

Description:

Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)

Treatment:

Device: Image fusion system

Control group (ZedTrauma)

No Intervention group

Description:

only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)